Overview
Sumatriptan is a serotonin receptor agonist commonly used to treat migraines and sometimes cluster headaches. Sumatriptan is the first of the triptans and was made available in Europe in 1991 to treat migraines. Sumatriptan was granted FDA approval on 28 December 1992.
Indication
A combination sumatriptan and naproxen tablet is indicated for the treatment of migraines with or without auras in patients 12 years of age and older. Sumatriptan nasal powder, nasal spray, subcutaneous injection, and tablets are indicated to treat migraines with or without auras in adults. One of the subcutaneous formulations of sumatriptan is also indicated to treat cluster headaches in adults, while the other subcutaneous formulation is not.
Associated Conditions
- Acute Migraine
- Acute Cluster headaches
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/23 | Not Applicable | Completed | |||
2024/07/16 | N/A | Recruiting | |||
2022/12/16 | Not Applicable | Completed | |||
2022/01/27 | Not Applicable | Completed | |||
2021/11/05 | Phase 4 | Completed | |||
2021/10/01 | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | ||
2021/07/01 | Phase 3 | UNKNOWN | |||
2020/12/30 | Early Phase 1 | UNKNOWN | |||
2020/04/21 | Phase 1 | Completed | |||
2020/02/06 | Phase 4 | Completed | Damanhour Teaching Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| MedVantx, Inc. | 66116-413 | ORAL | 50 mg in 1 1 | 9/3/2009 | |
| Mylan Pharmaceuticals Inc. | 0378-5631 | ORAL | 50 mg in 1 1 | 7/16/2018 | |
| Physicians Total Care, Inc. | 54868-5978 | ORAL | 100 mg in 1 1 | 5/24/2010 | |
| Innovida Phamaceutique Corporation | 71800-901 | ORAL | 85 mg in 1 1 | 12/9/2020 | |
| GlaxoSmithKline LLC | 0173-0523 | NASAL | 20 mg in 1 1 | 3/22/2024 | |
| Cipla USA Inc. | 69097-644 | NASAL | 20 mg in 1 1 | 1/29/2021 | |
| Direct_Rx | 72189-404 | ORAL | 100 mg in 1 1 | 3/6/2023 | |
| DIRECT RX | 61919-408 | ORAL | 50 mg in 1 1 | 6/7/2016 | |
| Baxter Healthcare Corporation | 36000-289 | SUBCUTANEOUS | 6 mg in 0.5 mL | 10/6/2021 | |
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0224 | ORAL | 100 mg in 1 1 | 1/12/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| IMIGRAN INJECTION 6 mg/0.5 ml | SIN06744P | INJECTION | 6 mg/0.5 ml | 12/26/1991 | |
| SUMATRAN TABLET 50MG | SIN13667P | TABLET | 50mg | 6/26/2009 | |
| IMIGRAN TABLET 50 mg | SIN08419P | TABLET, FILM COATED | 50 mg( Equivalent to 70mg as Succinate) | 10/26/1995 | |
| SUMASON TABLETS 50MG | SIN17179P | TABLET, FILM COATED | 50mg | 2/12/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Sumatriptan Succinate Capsules | 国药准字H20040699 | 化学药品 | 胶囊剂 | 8/3/2020 | |
| Sumatriptan Succinate Tablets | 国药准字H20030086 | 化学药品 | 片剂 | 5/28/2020 | |
| Sumatriptan Succinate Tablets | 国药准字H20040700 | 化学药品 | 片剂 | 8/21/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SUMATRAN sumatriptan (as succinate) 50 mg tablet blister pack | 187216 | Medicine | A | 5/11/2012 | |
| SUMATRIPTAN-WGR sumatriptan (as succinate) 50 mg tablet blister pack | 267423 | Medicine | A | 1/3/2018 | |
| SUMATRIPTAN ARROW 100 sumatriptan 100mg (as succinate) tablet blister pack | 117727 | Medicine | A | 7/10/2007 | |
| IPTAM sumatriptan (as succinate) 100mg tablet blister pack | 124087 | Medicine | A | 8/15/2006 | |
| SUMATRIPTAN-WGR sumatriptan (as succinate) 100 mg tablets blister pack | 267424 | Medicine | A | 1/3/2018 | |
| SUMATRIPTAN INTAS sumatriptan (as succinate) 50 mg tablet blister pack | 267421 | Medicine | A | 1/3/2018 | |
| IMIGRAN MIGRAINE LACTOSE FREE sumatriptan 50 mg (as succinate) tablet blister pack | 410293 | Medicine | A | 6/9/2023 | |
| Sumatriptan 100 mg tablet bulk | 346507 | Medicine | A | 10/23/2020 | |
| Sumatriptan Tablets 50 mg (OTC) blister pack | 159389 | Medicine | A | 2/16/2009 | |
| CHEMMART SUMATRIPTAN sumatriptan 100 mg (as succinate) tablet blister pack | 160198 | Medicine | A | 6/18/2010 |
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